Drug substances are usually administered as part of a formulation in combination with one or more other agents that serve varied and specialized pharmaceutical functions. Dosage forms of various types may be made through selective use of pharmaceutical excipients. As pharmaceutical excipients have various functions and contribute to the pharmaceutical formulations in many different ways, e.g., solubilization, dilution, thickening, stabilization, preservation, coloring, flavoring, etc. The properties that are commonly considered when formulating an active drug substance include bioavailability, ease of manufacture, ease of administration, and stability of the dosage form. Due to the varying properties of the active drug substance to be formulated, dosage forms typically require pharmaceutical excipients that are uniquely tailored to the active drug substance in order to achieve advantageous physical and pharmaceutical properties.
(S)-3-(4-((4-(morpholinomethyl)benzyl)oxy)-1-oxoisoindolin-2-yl)piperidine-2,6-dione (“Compound A”), which is also known as CC-220, is an immunomodulatory compound that markedly inhibits TNF-α, IL-1β, and other inflammatory cytokines in LPS-stimulated hPBMC and human whole blood. TNF-α is an inflammatory cytokine produced by macrophages and monocytes during acute inflammation and is responsible for a diverse range of signaling events within cells. TNF-α may play a pathological role in cancer, inflammatory and immune-related diseases. Without being limited by theory, one of the biological effects exerted by Compound A is the reduction of synthesis of TNF-α. Compound A enhances the degradation of TNF-α mRNA and also potently inhibits IL-1β and stimulates IL-10 under these conditions. Further, without being limited by any particular theory, Compound A is a potent co-stimulator of T cells and increases cell proliferation in a dose dependent manner under appropriate conditions. In addition, without being limited by theory, the biological effects exerted by Compound A includes, but are not limited to, anti-angiogenic and immune modulating effects.
(S)-3-(4-((4-(morpholinomethyl)benzyl)oxy)-1-oxoisoindolin-2-yl)piperidine-2,6-dione and methods of preparing the same are described, e.g., in U.S. Patent Publication No. 2011/0196150, the entirety of which is incorporated herein by reference. Compound A has the following structure:

Due to its diversified pharmacological properties, Compound A is useful in treating, preventing, and/or managing various diseases or disorders. However, Compound A is prone to hydrolysis and poses chemical stability challenges. Therefore, a need exists as to dosage forms of Compound A having advantageous physical and pharmaceutical properties.